Clinical Validation of PolyDeep: an Artificial Intelligence-based Computer-aided Polyp Detection (CADe) and Characterization (CADx) System. Polydeep Advance 2.

February 21, 2025 updated by: Fundacin Biomedica Galicia Sur

PolyDeep Advance 2: Clinical Validation of PolyDeep. Randomized Clinical Trial with a Tandem Colonoscopy Design.

This study is a clinical validation of PolyDeep, a computer-aided polyp detection (CADe) and characterization (CADx) system. PolyDeep Advance 2 is a multicentric randomized clinical trial with a tandem colonoscopy design. The hypothesis of this study is that Polydeep assisted colonoscopy will reduce the number of missed adenomas in the first withdrawal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Colorectal cancer (CRC) is the most frequently cancer in western world. A fundamental tool for detection and prevention is the colonoscopy. The detection and endoscopic resection of colorectal polyps, the precursor lesion of CRC, can reduce CRC incidence and mortality. Adenoma detection rate is the most used endoscopic quality indicator. The improvement of this indicator is related to the reduction of postcolonoscopy CRC incidence and mortality.

Colorectal polyp diagnosis is based on endoscopic resection and histological analysis. An accurate optical diagnosis could avoid histological lesion of smaller lesions, reducing the costs associated with histological diagnosis. The NICE (NBI International Colorectal Endoscopic) Classification has proposed the use of high definition endoscopes that have Narrow Band Imaging. However, NICE must be used by endoscopists who are sufficiently prepared and who have overcome the learning curve. Therefore, optical histology diagnosis with high accuracy independently of the center and the endoscopist is necessary.

Computer Aid Diagnosis (CAD) systems based on Artificial Intelligence are experiencing exponential development in the field of medical image analysis. The development of the CAD system is based on the creation of large databases of endoscopic images and/or videos, on the training, development and validation of diagnostic algorithms in such databases and, finally, on prospective clinical validation in patients undergoing colonoscopy. The goal of CAD systems in colonoscopy is double. First, it aims to increase the detection of polyps (CADe) in general, and of adenomas and serrated lesions in particular. The second objective is to characterize (CADx) the histology of detected lesion.

PolyDeep CAD is a functional prototype. It is capable of detecting, locating and classifying colorectal polyps. In vivo validation data shows that PolyDeep has high diagnostic accuracy for polyp identification and that this accuracy can be accommodated This clinical trial is part of the clinical validation of PolyDeep. We will perform a randomized clinical trial with a tandem colonoscopy design with adenoma miss rate as the main objective.

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Ourense, Spain, 32002
        • Complexo Hospitalario Universitario de Ourense
      • Pontevedra, Spain, 36071
        • Complexo Hospitalario Universitario de Pontevedra
      • Vigo, Spain, 36211
        • Hospital Alvaro Cunqueiro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • First diagnostic colonoscopy performed after a positive fecal immunochemical test performed within the CRC screening program.
  • Surveillance after colorectal adenomas resection.
  • Authorization after reading the information sheet and singing the informed consent.

Exclusion Criteria:

  • Incomplete colonoscopy without cecal intubation.
  • Colonoscopies with insufficient intestinal cleansing (Boston Bowel Preparation Scale <6 or <2 in any of the evaluated segments).
  • Detected lesions without histological diagnosis.
  • Previous CRC.
  • Previous colonic resection.
  • CRC associated hereditary syndrome.
  • Serrated polyposis syndrome.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Technique followed by Combination
Back-to-back tandem colonoscopies by the same endoscopist. The first colonoscopy will be performed without PolyDeep (standard technique) followed immediately by another colonoscopy with PolyDeep (combination technique).
Diagnostic test: Standard technique First colonoscopy without PolyDeep
Standard technique First colonoscopy without PolyDeep
Active Comparator: Combination followed by Standard Technique
Back-to-back tandem colonoscopies by the same endoscopist. In this arm, the first colonoscopy with be performed with PolyDeep (combination technique) followed immediately by another colonoscopy without PolyDeep (standard technique)
Diagnostic test: Combination technique First colonoscopy with PolyDeep
Combination technique First colonoscopy with PolyDeep

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma miss rate (AMR)
Time Frame: 1 Year
AMR will be calculated as the number of adenomas detected on the withdrawal or portion in either group divided by the total number of adenomas detected during both withdrawals
1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Polyp miss rate
Time Frame: 1 Year
It will be calculated as the number of polyps detected on the withdrawal or portion in either group divided by the total number of polyps detected during both withdrawals
1 Year
Serrated lesions miss rate
Time Frame: 1 Year
It will be calculated as the number of serrated lesions detected on the withdrawal or portion in either group divided by the total number of serrated lesions detected during both withdrawals
1 Year
Diagnostic yield and lesions characterization
Time Frame: 1 Year
The diagnostic yield will be measure using sensitivity , specificity, Positive Predictive Value, Negative Predictive Value, likelihood ratios and Youden index. Histological diagnosis will be used as the gold standard.
1 Year
Withdrawal time. (First/second colonoscopy)
Time Frame: 1 Year
Withdrawal time between the two arms will be calculated and compared.
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacin Biomedica Galicia Sur

Collaborators

European Regional Development Fund
Ministerio de Ciencia e Innovacion, Spain
Asociación Española de Gastroenterología
Xunta de Galicia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2023

Primary Completion (Actual)

July 30, 2023

Study Completion (Actual)

November 17, 2023

Study Registration Dates

First Submitted

August 22, 2022

First Submitted That Met QC Criteria

August 22, 2022

First Posted (Actual)

August 23, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PolyDeep Advance 2.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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